A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)

NCT ID: NCT01668862

Last Updated: 2012-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-11-30

Brief Summary

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This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. The primary end points are Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is improvement in ultrasonography form randomization to End of study.

Detailed Description

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Conditions

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Lateral Epicondylitis (Tennis Elbow)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study arm A

Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space

Group Type OTHER

Autologous Human Platelet Lysate

Intervention Type BIOLOGICAL

Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space

Control Arm B

Subjects will receive one injection of Corticosteroid in the lateral epicondyle space

Group Type OTHER

Corticosteroid

Intervention Type DRUG

Subjects will receive one injection of Corticosteroid in the lateral epicondyle space

Interventions

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Autologous Human Platelet Lysate

Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space

Intervention Type BIOLOGICAL

Corticosteroid

Subjects will receive one injection of Corticosteroid in the lateral epicondyle space

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with clinical diagnosis of tennis elbow within the last 3 months
* Subjects both male and female, aged 18-60 years (both inclusive)
* Subjects who are willing to give informed consent and adhere to the study protocol

Exclusion Criteria

* Subjects aged less than 18 and more than 60 years
* Subjects with autoimmune diseases
* Subjects with immuno-compromised system
* Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
* Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
* Subjects who have received treatment with corticosteroid injections within the last 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasiak Research Pvt. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anant Joshi, Dr.

Role: PRINCIPAL_INVESTIGATOR

ASMI

Nicolas Antao, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hillway Clinic

Gauresh Palekar, Dr.

Role: PRINCIPAL_INVESTIGATOR

Surya Orthopedic Clinic

Locations

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Kasiak Research Pvt Ltd

Thāne, Maharashtra, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Kaushal Shah, Phd

Role: CONTACT

Phone: +91-22-41173472

Email: [email protected]

Facility Contacts

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Kaushal Shah, Phd

Role: primary

Other Identifiers

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KRPL/HPL-TE/11-12/003

Identifier Type: -

Identifier Source: org_study_id